Computer-Assisted Patient Navigation and Information Systems and Methods

ABSTRACT

A computer-assisted patient navigational communication system for receiving electronic and oral communications from a patient, scanning data to determine the medical needs of the patient, and displaying relevant information to appropriate medical personnel who can immediately advise the patient of the most appropriate source of medical assistance relating to the patient&#39;s identified symptoms.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. application Ser.No. 16/662,305 filed on Oct. 24, 2019, which is a continuation of U.S.application Ser. No. 15/548,694 filed on Aug. 3, 2017, now U.S. patent.No. 10,489,554 issued on Nov. 26, 2019, which is a U.S. National Phaseunder 35 U.S.C. § 371 of International Application PCT/US2016/017132filed on Feb. 9, 2016, which claims priority to U.S. ProvisionalApplication No. 62/113,937 filed on Feb. 9, 2015, the disclosures ofwhich are incorporated herein by reference. All publications, patents,patent applications, databases and other references cited in thisapplication, all related applications referenced herein, and allreferences cited therein, are incorporated by reference in theirentirety as if restated here in full and as if each individualpublication, patent, patent application, database or other referencewere specifically and individually indicated to be incorporated byreference.

COPYRIGHT NOTICE

This application contains material that is subject to copyrightprotection. Such material may be reproduced exactly as it appears inPatent and Trademark Office patent files or records. The copyright ownerotherwise reserves all rights to such material.

FIELD

This application relates to a technology-enabled service with anavigation system for efficiently engaging the patient in thetherapeutic paradigm for obtaining appropriate medical care for anexisting condition. The patient is provided assistance for efficientnavigation through the myriad levels of health care to the appropriatelevel and provider. Such navigation extends from supervised self-care toproper use of emergency rooms, specialists, hospitals, home healthproviders, and ancillary service providers to include imaging,laboratory, pharmacy, and therapies such as physical therapy, speechtherapy, psychotherapy, and others. Finally, the inventions of thisapplication can also extend to the services of 1) assessment, 2)diagnosis, 3) tests and treatment, 4) education, 5) engagement, 6)monitoring, and 7) management of a patient's health care and his/herwellbeing.

BACKGROUND

A most perplexing problem to a person suffering from pain or havingsymptoms of a health problem is identification of a proper, immediatesource of medical help. With chest pains, does the person rush to anemergency care facility only to learn of temporary indigestion? Does theperson with an apparent rash call his family physician, obtain anappointment and later learn that he needs an allergy specialist? Does aperson who notices a dark black discoloration on his arm and concludesthat it is identical to a melanoma image on the Google web siteimmediately rush to a dermatologist—only to later learn of a brownspider bite?

Health problems are perplexing, nerve racking and often result in timeand dollar costs for unnecessary, expensive emergency room visits, waittimes accompanied by anxiety for appointments with physicians or nursepractitioners, and further delays accompanied by more anxiety whilewaiting for laboratory tests, imaging services, radiologistinterpretations, etc.

A related problem is ineffective use of preventive medicine and wellnessprograms. No one seems willing to pay for monitoring services that earlydetect changes in physiological factors such as glucose, hemoglobin A1C,blood pressure, aberrant heartbeats, low oxygen saturation, inflammatorymarkers suggesting arteries at risk for plaque rupture, etc. Indeed,patients and other payers seem to respond to needs for preventivemonitoring only after incidents have required costly medicalappointments and physician advices. Similarly, individuals commonlydelay learning of how to cope with, among others, diabetes, COPD,cancer, smoking, and obesity until adverse complications forceconsideration of such matters, and even then, such information may bedifficult to timely obtain.

There is no known integrated and existing answer to the patient'sproblems of navigating through the sourcing of medical care providers,effective use of preventive medicine, and educational systems in ourmedical establishment. Moreover, the current system of providing medicalservices in this country prohibits the rational development and deliveryof a highly efficient, safe, and effective therapeutic paradigm forassessment, diagnosis, treatment, education, engagement, monitoring, andmanagement. Such a rational delivery system should provide a reliablepatient navigation system, an effective preventive medicine program, andinformative educational curricula. Delivery of this improved health caresystem should be provided on mobile platforms that comport with modernpatient expectations.

A primary reason for the lack of solutions to these problems is the lackof payment for such services and the lack of any potentialprofitability. In our health system, costs are reimbursed only formedical services that have been coded and submitted for payment to theMedicaid or Medicare payer or the insurance company or the third partypayer. Moreover, individuals are reluctant to pay for oral or textadvices that are devoid of face-to-face services. And persons will notpay for preventive medicine or informative programs until they recognizethe need which often does not arise until adverse health conditions andresulting complications occur. Solutions to these challenges would be asignificant advancement in the art.

SUMMARY

In spite of a lack of known profitability, high investment, high directand indirect costs, the assignee of this application has investedhundreds of thousands of dollars in the conception and development of apatient navigation system (sometimes referred to herein as “Grace ClinicOnline” or “GCO,” which are trademarks of the Applicant or its affiliatebut used herein for ease of reference to such system) for onlinedelivery of a defined therapeutic paradigm that includes patientnavigation to the proper medical provider, preventive medicine andinformation systems. Surprisingly, during the development of the system,market segments have been identified for which substantial time and costsavings can be quantified and for which there is evidence to suggestemerging demand. Accordingly, systems described in this application willprovide quantifiable cost and time savings which may lead to sufficientreimbursement to support a durable provision of the herein describedtechnology-enabled services. For example, Managed Care Organizations(MCO) that receive contracts for managing Medicaid and/or Medicarepatient populations for the states find it saves dollars when patientsare directed to proper medical providers rather than unilaterallyseeking unnecessary, high cost, emergency room care. Too, their costsare also significantly reduced by avoidance of hospital stays, and evenunnecessary physician appointments. Similarly, MCO's costs may besignificantly reduced when a patient with a chronic illness is timelydirected to proper medical care when his physiological data ismonitored, when the patient's problem is identified and the therapeuticparadigm applied prior to the cost of an ambulance, a trip to theemergency room, and/or a difficult-to-manage escalation in the cascadeof care. Significantly, some embodiments of the inventions of thisapplication also include low cost capability to enable physicians, theiroffices as well as clinics and hospitals to manage Medicare patientswith chronic conditions without face-to-face consultations. Indeed, someembodiments of the inventions of this application include an ElectronicHealth Record (EHR) and/or Electronic Medical Record (EMR) which enablesan exchange of information between the physician and the patient, andthe physician or staff is available to the patient around the clock.Finally, programs directed to better engagement of patients in their ownself-care and wellness will benefit patients of MCOs, particularly withthe technology-enabled service described herein that provides clinicalsupervision of the patient's self-care. Significantly, the systems ofthis application successfully integrate all of these functions.

In addition to MCOs, the benefits of the present inventions willimmediately be recognized by county, federal, and state prison systemsin which expensive guard trips to specialists such as cardiologists maybe minimized, prescriptions for probiotics may avoid trips to thegastroenterologists, etc. A low cost, online navigational tool providinga technology-enabled service for assessment, diagnosis, treatment,education, engagement, monitoring, and management will improve accessand quality while lowering the cost of tax supported medical care topatients including those receiving benefits from Medicaid, Medicare,Veterans Health Services, and governmental employees, in addition topatients in nursing homes, and prisons. Patients paying for their owncare and those receiving employee benefits, along with insurancecompanies and benefit plan administrators, will also recognize thebenefits of the inventions disclosed herein.

The present disclosure is premised upon a system having several primarycomponents. Preferably, they include one or more computer servershaving: 1) a system interface to receive external physiological data andquestion responses of the patient from sources such as a medical device(e.g., blood pressure monitor or glucose meter) communicating with amobile handset such as a cellphone, a medical kiosk, medical diagnosticdevices, at home medical devices such as integrated systems provided byHoneywell and other providers, and devices sold at local pharmacies,diagnostic information from similar devices and diagnostic medicaldevices at a prison facility, a nursing home, or a rehabilitationcenter, data from laboratories and radiologists, etc., and to store suchdata into an Electronic Medical Record (EMR) of the members orsubscribers of an organization; 2) an enablement unit containing thesystem EMR database, said enablement unit being programmed to scan theEMR upon request from navigation station personnel and/or upon fixedtime intervals, or in response to a triggering event (which may betemporal) or trend, to search for an abnormality of physiologicalfactors for each patient, and to route an identified need of the patientto the most appropriate response, which may be an automated responsesuch as an inquiry as to whether the patient took their blood pressuremedicine or an automated request for the patient to repeat their bloodsugar measurement, or if indicated, routing of the patient's conditionto medical personnel of the navigation stations; 3) an internal systemvisual interface enabling medical personnel of a navigation station toview the patient's data such as age, sex, health history, physiologicalconditions from the updated EMR including present symptoms, images,etc., and 4) a navigation station having inbound and outbound oral anddigital communication facilities for permitting automated patientengagement as well as interactions with medical personnel such asnurses, nurse assistants, physician assistants and physicians tocommunicate with the patient, to further obtain information from thepatient and to navigate the patient in need of medical help to the mostappropriate source of medical provisions. Engagement of the patient insupervised self-care at the nonclinical site through automatedinteractions with the system (e.g., “Your blood pressure is higher thanusual [or appears to be trending upward]; have you taken your bloodpressure medications today [or according to the prescribed schedule]?”or “Your blood sugar is low, please recheck it immediately”) providesthe earliest possible identification and intervention opportunities toimprove health, reduce the requirement for personnel staffing, and toreduce costly escalations in care. Such sources may include the entirespectrum of sources, i.e., from status quo to escalation of monitoringand therapeutic intervention at the current site of care, to initiationof emergency treatment and possible emergency transport to an escalatedsite of care. Such navigation provisions may also include acquisition ofnew data such as laboratory tests at the point of care or at alaboratory and/or imaging services, medical treatment, or referrals tophysicians, telemedicine consultations as well as recommendations foreducation, self-help, and advices. Finally, such provisions may includenot only navigation, but a direct communication, or alert to the patientas well as an exchange of information between the patient and caregivers(nurse assistants and/or primary care physicians) in the navigationstation or outside the station. Alternatively, the navigation stationmay alert the patient's PCP (Primary Care Physician) and facilitate acommunication directly between the patient and the patient's PCP.

Realizing that trained medical personnel may have both direct oraltelephone communications with a patient in anguish and immediate accessto the patient's EMR and incoming data through devices such as remotemedical devices, tablets, and smartphones, Applicant has developed anavigation and communication system that may substantially reduce thecost of medical care for various organizations responsible for thehealth care costs of their members, employees, policy holders, andassociated persons such as, for example, state government employees,prisons, nursing homes, corporations and business entities withsubstantial employees and insurance companies, such as Blue Cross BlueShield™ and others. Accordingly, various embodiments described hereinmay:

1) provide timely, accurate, cost saving, navigational guidance toindividuals as to the most appropriate health care provider for theindividual's condition;

2) obtain access in digital form to all of the available patient healthdata of associated individuals, including prior claims data, togetherwith current data from kiosk, at-home monitors, manually entered patientdata, orally entered patient data, pictures of patient data or physicalfindings, telemedicine data, data from physiological devices havingdirect connectivity or wireless communication such as BlueTooth, Wi-FiCellular Data, USB to PC or other connectivity, and MicrosoftHealthVault™, for example, and/or interface with and store new data inthe EMR of a member, employee, prisoner, etc.;

3) analyze updated EMR on a call basis and on a time interval basis toidentify abnormalities in physiological factors and route abnormal datato appropriate navigation to automated algorithms and other machinesystems and, as indicated, to trained medical personnel to respond;

4) provide a visual interface (and oral interface) with a summary of theupdated EMR to trained medical personnel of the navigation stations fororal and data inbound and outbound communications with the individual(which may include, for example, videophone communication applicationssuch as FaceTime™) to guide said individual to the most appropriateself-care responses or health care provider for the existing conditionsof the patient;

5) provide inbound and outbound audio and video and data connections tothe individual for further evaluating the health condition of thepatient and needs for a health care provider, formulate advice,communicate it clearly, and simultaneously make arrangements forimplementing said advice through referrals, appointments, lab tests,imaging, home health visits, prescriptions, emergency room and/orambulance services, as patient conditions and capabilities dictateappropriateness, etc.;

6) provide for the assessment, diagnosis, tests and treatments,education, engagement, monitoring and management of patient wellness andhealth, particularly where patients with chronic diseases can be wellserved by continuous and/or repetitive monitoring of physiologicalconditions by a physician or his staff around the clock; and

7) communicate with both the patient and his PCP with regards to alertsand abnormalities of the patient's health condition, to providereminders to both the patient and to the PCP as to the need forphysiological data readings and needed inputs into the system and, whereappropriate, enable the PCP to access the patient's portal and reviewhis EMR data.

In some embodiments, a computer assisted navigational communicationsystem for immediate determination of a remotely monitored medicalpatient's needs and for guidance of the patient to the proper medicalprovider responsive to the patient's symptoms may include: an externalsystem interface configured for receiving patient data, includingphysiological data and historical medical data, pertaining to thepatient from one or more of the following sources: a kiosk withphysiological diagnostic equipment; home health monitors withcommunication connections; facility equipment ofprisons, nursing homes,and rehab centers; various employer institutions; consulting physicians;laboratories; and imaging centers; and formatting said patient data in aprescribed format to form EMR data; an enablement system configured foranalyzing the EMR data, identifying an abnormality, and transferringinformation pertaining to the abnormality to navigation personnelassociated with a navigation station of the system having credentialssuitable to direct the patient to an appropriate medical care provider;an internal system interface configured for providing a combined view ofthe EMR data to the navigation personnel; and a navigation stationconfigured for inbound and outbound oral and data communications betweenor among two or more of the patient, receptionist, nurse, physicianassistant, physician, and other medical providers including one or moreof the following: pharmacy, lab, imaging facilities, family andspecialist physicians, emergency rooms, hospitals, ambulance services,and rehabilitation services.

In some embodiments, a low cost method for efficiently navigating apatient to the appropriate medical provider for the purpose of avoidingunnecessary costs of facilities such as emergency rooms when appropriatemay include: providing members of an organization with a member ID andpassword for communicating their physiological data via voice and datacommunications to a navigation system; receiving the physiological dataand placing same in an EMR for each respective member; scanning the EMRto identify one or more abnormalities of the physiological data;displaying the EMR upon a visual display and alerting a navigationstation that the EMR is being displayed; and communicating throughelectronic and oral communications between the navigation station andthe relevant member for whom the one or more abnormalities wereidentified to direct that member to the most appropriate medical serviceprovider for such member's health condition.

In some embodiments, a low cost system for providing medical services toa remote patient may include: (a) a system call center configured forcommunications between a medical service provider and the patient; (b)the call center having access to the patient's Electronic MedicalRecord; (c) the call center having computer facilities configured forreceiving physiological data from the patient through one or more of thefollowing modes: fax, videophone, medical devices connected to theinternet, photos of interfaces; (d) the computer facilities having oneor more interfaces configured to immediately display the physiologicaldata of the patient and the Electronic Medical Record; and (e) the callcenter having medical professionals available to immediately review thephysiological data and the Electronic Medical Record through a computerinterface, and to simultaneously communicate with the patient todirectly obtain information to enable the medical service provider torender one or more of the following services: assessment, diagnosis,treatment, education, engagement, monitoring, and managing the patient'scondition.

In some embodiments, a low cost system may be provided for accuratelycommunicating physiological data from a remote patient to a medicalservice provider at a call center for assessment, diagnosis, ortreatment of the patient's medical condition. The call center may beconfigured for receiving a dual tone multi-frequency sound and fordisplaying information representative of the dual tone multi-frequencysound on a visual interface to enable the medical service provider toassess, diagnose or treat the patient. The call center may include aninteractive voice response system configured for receiving a dual tonemulti-frequency sound representative of the physiological data andplacing the physiological data in memory for analysis. Such low costsystem may include: (a) a physiological monitor configured formonitoring a physiological condition of the patient and a means forcommunicating physiological data concerning the patient from the monitorto a dongle; (b) a dongle configured for receiving the physiologicaldata from the monitor and converting the physiological data into a dualtone multi-frequency sound adapted for transmission to the call center;and (c) a phone configured for receiving the dual tone multi-frequencysound from the dongle and transmitting the dual tone multi-frequencysound to the call center.

BRIEF DESCRIPTION OF THE DRAWINGS

The manner in which the above functionalities are obtained is describedin the following detailed description and the drawings, in which:

FIGS. 1A and 1B are a block diagram depicting system functionality andinformation exchange therein of an embodiment of the present inventions.

FIG. 2 is a schematic diagram illustrating another embodiment of ahealth care navigation system as described herein.

FIG. 3 is a schematic diagram further illustrating a portion of thesystem of FIG. 2.

FIG. 4 is another schematic diagram illustrating yet another embodimentof a health care navigation system as described herein.

FIG. 5 is another block diagram illustrating various aspects of a healthcare navigation system as described herein.

FIG. 6 is a listing of various specialists that may participate in ahealth care navigation system as described herein.

FIG. 7 is a high level schematic diagram illustrating basicfunctionality and interaction of an embodiment of a health carenavigation system as described herein.

FIG. 8 is a schematic diagram illustrating various layers of anembodiment of a health care navigation system as described herein,showing all workflow focused on the final outcome of service provision.

FIG. 9 is a network diagram illustrating a sample configuration oftechnology that may be used to implement a health care navigation systemas described herein.

FIGS. 10A and 10B are a process flow diagram illustrating a sample usecase scenario showing process flow applied when a monitor entry is dueby a remotely monitored person.

FIG. 11 is a schematic diagram illustrating an embodiment of a DTMFDongle that allows for data collection from a remote monitor device andsending such data to GCO.

DETAILED DESCRIPTION

As illustrated in the right hand column of FIG. 1B, Applicant's systemmay receive patient physiological data from sources that include kioskshaving glucose monitors, ECG devices, blood pressure cuffs, oxygensaturation devices, temperature monitors, respiratory rate monitors,cardiac output and stroke volume monitors, and the like. Similarly, athome monitors may provide the same or similar data. Such information maybe transmitted via Wi-Fi, Blue tooth or other wireless communicationcapabilities of the monitors and devices, e.g., from USB portsincorporated into the devices and connected to personal computers ortablets having internet or wireless access, etc. Another source is thepatient who reads the output of the devices and transmits them, e.g.,via a desktop computer or smartphone, to the patient's portal on thesystem. Other sources of information for the system include diagnosticpatient data from facilities such as nursing homes, prison infirmaries,rehabilitation centers, prior claims from a MCO, data from laboratories,and external databases, etc. Similar information may be accessed fromthird party health records, which may include sources such asMicrosoft's HealthVault™, health information exchanges, fitness portals,and other services. Finally, another external source is the patient'saudio, video, and data communication through a telephone and/or othercommunication devices. Indeed, oral and video communications enablingthe patient to speak directly to the medical personnel using the systemmay be preferred as significant information is often best solicited fromastute questions of the medical personnel as well as the voice andvisual demeanor of the patient.

As noted earlier, one benefit of some embodiments of the inventions ofthis application is the immediate provision of the most appropriateservice and navigation instructions to the patient. Exemplary outputs ornavigation provisions from the system are illustrated in the left handcolumn (Services Rendered) of FIG. 1A. Where the symptoms and data fromthe patient indicate no serious health problem, the patient may bemerely provided with advice, or alternatively directed to an educationand self-care video regarding a specific health problem. Such videos mayextend from the need for patient review of conditions such as weightloss, smoking cessation, minor complications with a pregnancy, etc., tohighly sophisticated explanations for self-care of complex and co-morbidconditions, such as by way of example chronic pulmonary disease causallyassociated with cardiac electrical rhythm aberrancy, and when monitoredcardiac rhythm aberrancy worsens, how to check pulmonary status as, byexample, with spirometry and pulse oximetry, and then escalate pulmonarytherapy such as by administration of home oxygen or byself-administration of breathing treatments by physician-prescribedmedication protocols. With ongoing monitoring, patient education andactive engagement, and supervision (herein, “supervised self-care”),highly effective and cost effective care can be safely administered evenin home settings, whereas such sophisticated care would previously onlybe delivered in a high cost setting such as an intensive care unit. Whenthe symptoms and data from the patient indicate serious health problems,such as slurred speech and inability to control an arm or appendage,ambulances may be ordered, the emergency room advised of the possibilityof an incoming stroke victim, etc. Between these provisions of mereadvice and emergency procedures is a host of other services, includingremote clinical consultation, ordering of blood and urine tests,compliance reminders, requests for monitor calibration, referrals tofamily physicians and/or specialists, etc.

The present systems may provide immediate analysis of the input datafrom the devices and the patient, display of the data and analysis tomedical personnel, and immediate advice as to the most appropriatemedical provider and service available based on the patient's actualneeds. To accomplish these results, the systems and methods of FIGS.1A-1B include an interface management system (10) having an externalinterface (12) for receiving data from the sources mentioned earlier andfor translating that data into a standard format and storing it in theEMR of the system. For identification of the patient, the MCO that seeksto reduce its health care costs may provide its members with an ID forentry of their data into the system. In the alternative, employers,prisons, and others who contract for navigational care may haveavailable kiosks with physiological monitors available for obtaining theinformation and immediately transmitting same to the system. Too, thepatient can obtain data from his home monitors and transmit same withhis smartphone, tablet, or other computer device or manually enter thedata through a patient portal on the interface (12) of the system (10).

As well known in the art, computer programs for interfacing the incomingdata into the system interface 12 are commercially available or readilycreated, and persons skilled in the art can use these programs as wellas modifications thereof to receive, format, and store the incoming datain the system EMR. In addition, each patient is preferably provided witha patient portal to access his/her EMR, to obtain access to self-helpand education programs pertinent to his/her health.

The system EMR is part of the care enablement system (14) which isherein described as a technology-enabled service delivering supervisedself-care and navigational support. Preferably, it comprises a datarecord stored in a database with various fields for each data type,e.g., blood pressure, glucose reading, oxygen saturation, etc. Thefunction of this enablement unit is to search and/or scan the EMR forabnormalities upon receipt of the data or, alternatively, at timedintervals, or in response to defined events in the system. When found,an alert is transmitted to the navigation personnel (18) for action.This scanning can be performed upon receipt of the data and storage inEMR. In addition to scanning for abnormality, the enablement system (14)can be programmed to search for changes or emerging trends in theindividual's data. For example, if systolic readings were normally 110and suddenly, a new reading as high as 180 were received, the enablementsystem can be programmed to direct the navigational personnel to make anoutbound communication to the patient to inquire of the potential causefor the change. Such early detection and preventive medicine may wellavoid costly appointments, hospital stays, etc.

Upon determination of abnormalities or receipt of patient concerns anddata analysis, the enablement system (14) may be programmed to firstverify the abnormality is correct by rechecking the information orfollowing other automated algorithms based on the incoming data and thenif indicated route the inbound call or text problem of the patient, orthe alert of abnormality, to the most appropriate medical person tonavigate the patient to the most appropriate health care provider of thenavigation station (18). To achieve this result, personnelqualifications such as credentials, areas of special knowledge,languages, and other evaluated skills of the medical care personnel inthe navigation station (18) are input and may be associated with varioussymptoms, chronic diseases, communication barriers and other factors.For example, an abnormality alert for a trend of increasing glucosereadings in a diabetic patient might be routed to a nurse with deepexperience evaluating and counseling chronic diabetes patients, whereasa call from a patient with stuttering and loss of movement might berouted to a physician MD or a physician's assistant with a focus onemergency care. Algorithms for first verifying the correctness of theincoming abnormal data and then weighting the various factors andassociating certain personnel with specific conditions and symptoms maybe used.

Simultaneous with the routing of a specific patient problem to aspecific person on the navigation station (18), the EMR of the patientand all related data may be placed upon the internal system interface(16) to display the EMR and related data to navigation personnel. Inaddition, the pertinent navigation personnel may accept the inbound callor electronic communication from the patient and begin a furtherclinical protocol discourse to elicit any additional desired informationfrom the patient. Additional pertinent information received may be addedby the navigation personnel to the patient's EMR. After evaluating theinformation received, the navigation personnel may begin delivery of theappropriate option from the available “services rendered,” which mayinclude directing the patient to the most appropriate health careprovider. Such may include directing the patient to any of the sourcesof the left column of FIG. 1A. Alternatively, it may be appropriate forthe medical personnel of the navigation station 18 to directly providethe needed medical advice, or alternatively to bring the PCP into thediscussion.

Another benefit of these systems is the ability to monitor patient datacontinuously or at time intervals as needed. For example, many patientswill be requested by their health care providers to submit physiologicaldata pertaining to their health condition periodically, e.g., weekly, orseveral times a day. For more serious conditions, physiological datasuch as ECG and O2Sat may be submitted substantially continuously. Thecare enablement system (14) may be programmed to scan and search forabnormalities on a regular time interval basis or upon events such asimmediately upon receiving new data for the patient. In the event anadverse or abnormal condition is detected, the unit may direct theappropriate navigation station personnel to clinically evaluate the dataand take appropriate action. Alternatively, notifications of problems,reminders to provide data, status communications, and the like may bedirectly provided to the patient and/or to the patient's PCP.

It is also contemplated, as reflected in FIGS. 1A-1B, that data from thepatient may be accepted, converted to the EMR of the enablement system(14), and analyzed on a 24 hour basis. Similarly, inbound calls orelectronic communications from the patient may be made at any time ofthe day or night. As an alternative, the navigation system can be usedby a PCP or his staff who, by accessing the EMR of the system, canreview, directly contact, and manage chronically ill patients on a 24hour basis. Alternatively, the PCP can delegate this function to aphysician or nurse assistant of the navigation station (18).

As appreciated by persons skilled in the art, numerous modifications mayeasily be made to the systems and methods described above. Onebeneficial modification is to add a navigation analysis system to insurequality and timely response by the personnel of the navigation station(18). For example, if the number of inbound calls exceeds a prescribedlimit, e.g., 4 calls per navigation person, additional navigators may beadded immediately. Similarly, if the wait time for any patient exceeds aprescribed limit, e.g., five minutes, additional navigators may be addedimmediately. Similarly, additional sources of medical providers canalways be added to the left column of identified providers, anddifferent interfaces can be added to accommodate inbound data from otherdevices or additional sources. Finally, special criteria may be added inthe form of additional scan parameters for searching the EMR's toidentify specific health conditions and problems. Accordingly, all suchadditions and modifications are contemplated as within the scope of theinventions set forth in the following claims. If the patient has ahealth condition that requires daily monitoring and/or input ofinformation, the system may be programmed to receive such data, and ifnot received, the care enablement system (14) may be programmed to sendan instruction to the most appropriate navigation station 18, oralternatively, to send a reminder directly to the patient member toprovide the required data, for example, his glucose reading or his bloodpressure.

Referring to FIG. 2, in some embodiments, a supervised health carepatient navigation system 100 may have a central computer 112 incommunication with a plurality of service provider computers 114associated with a respective plurality of health care service providersS1 . . . Sm (e.g., doctors, therapists, labs, and the like) and aplurality of patient computers 116 associated with a respectiveplurality of patients P1 . . . Pn via one or more networks 118, e.g.,the Internet, telephone, and/or other suitable communication networks. Aplurality of health care navigators N1 . . . Nr (e.g., doctors, nurses,physician assistants, and the like) may provide input to and receiveoutput from central computer 112 either directly or through respectivenavigator computers 120. Communication between central computer 112 andnavigator computers 120 may also be through the one or more networks118. Central computer 112 may serve as a secure central repository ofhealth care data concerning the plurality of patients P1 . . . Pn aswell as a communication hub for the various persons described herein.Health care navigators N1 . . . Nr may communicate with patients P1 . .. Pn and service providers S1 . . . Sm to coordinate health careservices for the patients through network 118, which may include any ofa number of different types of communication, such as regular telephonecommunication, text messages, electronic mail, videoconferencing, orother suitable forms of communication, some or all of which may occursubstantially simultaneously or sequentially.

Referring to FIG. 3, in some embodiments, each patient P may have one ormore sensors 122-126 (sometimes referred to herein as monitor devices)configured to measure one or more physical characteristics, e.g.,weight, heart rate, blood pressure, blood glucose level, blood oxygenlevel, ECG signals, or any other measurable physical characteristic of apatient. Sensors 122-126 may be attached to or embedded in the patient Por they may be separate from the patient P. In some embodiments, sensors122-126 may be worn by a patient periodically or substantiallycontinuously. In some embodiments, sensors 122-126 may be part of akiosk in which a patient P may sit, stand, or lie down. Sensors 122-126may send data representative of the one or more physical characteristicsof the patient P to patient computer 116, which may send such data tocentral computer 112 via the one or more networks 118. Such sending ofpatient data may be manual, automatic, or in response to a command orrequest, and such sending of patient data may be substantiallycontinuous, periodic, or discrete. Subject to appropriate permissions,each service provider S may access such patient data on central computer112 pertaining to each patient P to whom service provider S is providinga health care service through a service provider computer 114 and theone or more networks 118. Such patient data may be “pushed” to eachservice provider computer 114 or navigator computer 120 by centralcomputer 112 based on certain criteria, or such patient data may be“pulled” from central computer 112 by each service provider computer 114or navigator computer 120 upon request. Each patient P may also accesshis or her patient data on central computer 112 via patient computer 116and the one or more networks 118.

Still referring to FIG. 3, each patient P may also have a video camera128 (e.g., a web cam in communication with the one or more networks 118via patient computer 116) and a microphone and speaker 130 (e.g., atelephone) in communication with the one or more networks 118, which mayalso be via patient computer 116. Similarly, each service provider S mayalso have a video camera 132 (e.g., a web cam in communication with theone or more networks 118 via service provider computer 114) and amicrophone and speaker 134 (e.g., a telephone) in communication with theone or more networks 118, which may also be via service providercomputer 114. Likewise, each navigator N may also have a video camera136 (e.g., a web cam in communication with the one or more networks 118via navigator computer 120) and a microphone and speaker 138 (e.g., atelephone) in communication with the one or more networks 118, which mayalso be via navigator computer 120. Each patient computer 116, serviceprovider computer 114, and navigator computer 120 may have a displayconfigured for displaying video data and patient data. As persons ofordinary skill in the art will appreciate, using this system, anavigator N may direct a patient P to the most appropriate serviceprovider S based on the patient's needs, and such service provider S mayprovide health care services to a remote patient P in a virtualenvironment in which some or all of the service provider S, the patientP, and the navigator N may see and hear each other in substantiallyreal-time communications (hereafter, a virtual patient visit). Ofcourse, for hearing impaired or visually impaired patients or serviceproviders, alternative I/O devices may be utilized in order to providethe appropriate forms of communication for such persons. Before, during,and after a virtual patient visit, the service provider S and thepatient P, as well as the navigator N, may have access to the patient'sdata (EMR) on central computer 112 via the one or more networks 118 tohelp facilitate the rendering of health care services to the patientusing up-to-date patient data. Another possible arrangement of such asystem is shown in FIG. 4.

A health care navigator N, who may also have access to patient data oncentral computer 112, may help facilitate the rendering of appropriatein person or remote health care services to each patient P by one ormore appropriate service providers S, some or none of whom may bepresent in the same location. An actual or virtual patient visit mayinvolve one or more service providers S. For example, based on theparticular patient data, a health care navigator N may facilitate avirtual patient visit among the patient P, a primary care physician, anda specialist physician. If applicable, a pharmacist or rehabilitationspecialist, for example, may also join the virtual patient visit. When apatient contacts such a health care navigator N, the health carenavigator N may effectively conduct triage, and the most appropriatehealth care services may be provided to the patient P based on thepatient's actual needs as reflected by up-to-date patient data. Thismethod reduces the cost of providing health care services, improves thequality of care, and enables remote patients to receive health careservices from specialists and other health care providers whom thepatients otherwise would be unable to access.

Each patient P may also access a variety of health education materials(e.g., articles, videos, presentations, and the like) provided oncentral computer 112 via a patient computer 116 and the one or morenetworks 118. Such health education materials may be tailored for eachpatient P based on the patient data stored on central computer 112. Forexample, a patient P who suffers from diabetes and high blood pressuremay be granted access to educational materials for those specificdiseases, but such patient may or may not also have access toeducational materials that pertain to other diseases or conditions.Based on the patient data stored on central computer 112, each patient Pmay be directed to the health education materials that are mostbeneficial to the particular patient. In this manner, each patient P maybe empowered to assume greater responsibility and accountability for hisor her health care, thereby reducing the overall cost of health care andmaking it more efficient, yet providing appropriate supervision byqualified medical personnel to enhance the likelihood of positiveoutcomes for each patient.

In some embodiments, the health education materials may comprise videosin which professional actors, rather than physicians, for example,convey the health education information. Professional actors maycommunicate the relevant health education information to patients in amanner that is much more engaging and understandable for patients, whichimproves the likelihood that the patients will understand and act on theinformation, thereby improving patient outcomes.

Based on the patient data stored on central computer 112, centralcomputer 112 may also prompt a patient P to take certain actions withrespect to his or her health care by sending messages to patientcomputer 116. For example, if a patient's treatment plan calls forcollecting a certain measurement by a certain date, central computer 112may prompt the patient P on or in advance of such date to take themeasurement and input the measurement data into patient computer 116 fortransmission to central computer 112 via the one or more networks 118.Additionally, if the patient misses a particular deadline, centralcomputer 112 may prompt the patient P with a reminder concerning thesame. In some embodiments, central computer 112 may send one or morealert messages to a patient if the patient data on central computer 112indicates an emergency or other adverse condition exists or is about tooccur so that the patient may take corrective action, which may beindicated in the alert messages. In some embodiments, appropriate actionitems pertaining to a particular patient may be included in or with theeducational materials that are tailored for that particular patient. Forexample, if a patient suffers from asthma, an educational article onasthma may include a link that takes the patient to his or herspecifically tailored action item plan for asthma. A navigator may helpfacilitate such actions as well.

In some embodiments, central computer 112 may be configured to grantvarious rewards to patients based on their compliance with theirparticular health and wellness plans. For example, if a patient P meetsall or a certain percentage of his or her action items (e.g., reviewingcertain health education materials, sending in certain measurements, orthe like), such patient may receive a cash award, a discount on certaingoods or services, a virtual medal, one or more points toward a rewardprogram, a better insurance rate, a lower deductible, or some othersuitable reward.

In some embodiments, central computer 112 may be configured to providean online portal for each patient P who subscribes to the service. Froma home page, each patient may access a variety of resources, includingone or more health and wellness plans tailored for each patient. Forexample, a given patient may have a smoking cessation plan, a diabetesmanagement plan, and a cholesterol management plan. Each health orwellness plan may have one or more programs that are also tailored foreach patient. A patient's portal may also include various monitors,alerts, health risks, action items, information, and announcements. Insome embodiments, the patient data for each patient on central computer112 may include a continuity of care document having a standard dataformat for ease of use by multiple service providers S.

In some embodiments, central computer 112 may be configured tocoordinate telephone communication, videoconferencing, and onlinecommunication among health care service providers S1 . . . Sm, patientsP1 . . . Pn, and health care navigators N1 . . . Nr in a manner thatentails low enough cost and efficiencies of scale to achieve synergisticresults that could not be achieved otherwise. For example, with theaggregate patient data that may be collected by central computer 112,data analytics may be employed by central computer 112 to identifyvarious social determinants of health, such as educational focus, careerplanning, reading activity, partner selection, parenting skills,mentorship, physical fitness, substance abuse, physical or emotionalabuse, and the like, and appropriately tailored education and actionitems may be provided to each patient in view of those analytics and thepatient's particular health data. One aspect of the systems and methodsdescribed herein that may yield such beneficial results is that eachpatient P is empowered, via the online information portal, to assumegreater responsibility and risk for his or her health care, along withreceiving appropriate incentives for such assumption, thereby consumingfewer health care resources. Another aspect is that each service in theoverall system of health care services may be performed by the lowestcost resource initiated first with machine logic then progressing to atier of personnel who are qualified for the particular service. Optimalutilization of this online healthcare system may produce substantialimprovement in health and reduction in healthcare costs; however,achieving these results may require timely patient interaction,including the input of requested information and compliance with systemrecommendations. In some embodiments, an explicit goal of the systemherein taught may be that rewards and withholding of rewards may beallocated according to the performance of each patient. One of thepreferred embodiments for the rewards may be allocation of mobileminutes, data, internet access, handset upgrades, and other desiredattributes of cellphone services as a reward for high performingpatients. High performing patients may rely on the machine logic of thesystem; lower performing patients may rely more on the clinical staffwhich will cost much more. Even so, the system will triage the patientaccording to the required level of care. For example, in someembodiments, the health care navigator N role may be fulfilled byproperly educated nurses or physician assistants rather than physicians,and a lower cost but qualified specialist may be used rather than ahigher cost specialist, when appropriate, based at least in part on theaggregate patient data collected by central computer 112.

FIG. 4 shows a more detailed embodiment of the GCO system described inFIG. 3. The GCO internal network 600 shows a possible network topologythat may meet the needs of GCO Navigation Staff. The call centerworkstation may provide telephony for communicating with patients,remote care staff, and medical specialists. An attached or embeddedcamera may provide means for video conferencing with patients, medicalspecialists, and/or remote care staff. The communications gateway (suchas a private branch exchange) may provide this rich suite ofcommunication options. The GCO application server 602 may provide workflow control for the GCO Navigation Staff as well as web presence to thepatient for interaction with his or her medical data. The patient sidenetwork topology 603 may be as simple as a cell phone for upload ofinformation via voice, keypad input, or a mobile application. For thosecircumstances where the patient has a remote monitor 604, for example ablood pressure meter or a blood glucose meter, the GCO embodiment maysupport various options to upload the data via a home PC, cell phoneapplication, and voice or keypad entry via a phone, for example.Additionally, a deployed telemedicine kiosk 605 may provide the monitorsuite and connectivity to gather data from the patient and allowcommunication to the Navigation Staff. In some instances, if thetelemedicine kiosk 605 is not normally in the same location as thepatient, the patient may need to travel to the location of thetelemedicine kiosk 605. The final piece of this GCO embodiment maysupport the remote staff and consultants who provide medical services asshown at 606. On the medical specialist side, a home PC may be suitablefor the job, for example, or a specially deployed telemedicine kiosk PCmay be desired for a more advanced service level in some instances. Onthe more advanced side of the application, remote care staff, forexample a home health care worker or prison infirmary staff, may utilizea specialized remote care suite 607 that may allow for a higher servicelevel. Such a specialized remote care suite 607 may employ FDA approvedmonitoring devices, for example, for data acquisition from the patientin support of critical care. In addition, remote care suite 607 mayemploy higher resolution cameras with embedded actuators, for example,supporting remote control for examination purposes.

Referring to FIG. 5, in some embodiments, the foregoing functionalitymay be implemented in the form of a clinical management organization asshown. The computer assisted navigation station 18 referenced above maytake the form of a navigation center with one or more navigators N,which may coordinate health care services for a plurality of patientswith the respective PCPs and a variety of specialists, examples of whichare illustrated in FIG. 6. The system may be used to assess, diagnose,treat, manage, and monitor the medical conditions of each patient andeducate each patient according to his or her specific needs.

FIG. 7 illustrates the high level features of GCO. Typically, theremotely monitored patient must transport healthcare data 400 (e.g.,from sensors 122-126 noted above, manual entry, or otherwise) to the GCOApplication, which may run on central computer 112 described above, forexample. This communication of data 400 may occur in a number of waysthat span voice, encoded audible signal, high frequency modulatedsignals such as modems, file transports such as FTP, and standardInternet transmission protocols, for example. The data 400 may includeany information that may be collected directly from the patient, such asa depression scale, or collected from a remotely deployed device like ablood pressure monitor, for example. Additionally, this data may derivefrom other sources such as Managed Care Organizations, HealthInformation Exchanges, participating providers' electronic medicalrecords, and peripheral service providers like clinical laboratories,imaging centers, and pharmacies, for example. From there, the GCOApplication may analyze the data and organize tasks based on clinicalprotocols as indicated at 401. At this point, the GCO Application mayassign tasks to the GCO Staff (e.g., navigators N discussed above)and/or launch automated processes that communicate with the patientwithout involving human resources as indicated at 402. In someembodiments, the tasks assigned to the GCO Staff may range into threebroad categories. First, the GCO Staff may coordinate basic healthcareneeds for a patient as indicated at 403, such as doctor appointments orlaboratory tests, for example. Second, the GCO Staff may get externalspecialists involved for consultation with the patient and GCO Staff asneeded as indicated at 404. Third, the GCO Staff may contact theremotely monitored patient directly to provide assistance and medicalcoaching as shown at 405.

FIG. 8 illustrates a layered viewpoint of GCO. This figure shows how allthe workflow embodiment within each layer ultimately results in theprovision of services 501 to the patient as shown at 500. The servicesmay cover a spectrum of healthcare needs covering education,consultation, referrals and appointments, advocacy, and test andtreatments. The GCO Resources which provide these services may varybetween automated systems such as auto-dialers and web applications(e.g., controlled by the GCO Application on central computer 112) tohuman resources (e.g., navigators N) such as medical staff, supervisors,and administrators. The supporting foundation of the services is thehealthcare data that must be transported as shown at 502 to the internalworkings of the GCO system. As explained in connection with FIG. 7, thistransport or communication of such healthcare data can occur in a numberof ways that span voice, encoded audible signal, high frequencymodulated signals such as modems, file transports such as FTP, andstandard Internet transmission protocols, for example. The data canderive directly from the patient input or it can be collected from aremotely deployed device like a blood pressure monitor, for example.Additionally, this data may derive from other sources such as ManagedCare Organizations (MCOs), Health Information Exchanges (HIEs),participating providers' electronic medical records, and peripheralservice providers like clinical laboratories, imaging centers, andpharmacies, for example. The GCO external system interfaces maytransform the data as shown at 503 to a format understandable byapplication logic as necessary. Thereafter, the GCO Application canperform analysis of the data and create tasks as shown at 504 inaccordance with the needed actions as determined by the analysis. TheGCO internal system interfaces may perform routing and delivery of tasksas shown at 505 to the various GCO Resources, whether human or automatedor both, as applicable.

FIG. 9 illustrates one of many options showing a sample network topologythat may be used to implement a GCO embodiment. A GCO App Server 200coupled with a GCO DB Server may provide the main application logic anddata storage needs. The GCO App Server may include a web server that canexecute and interpret HTTP requests and responses. This may allow forpatient and staff interaction with the GCO system through an Internetbrowser, for example. A PBX Cluster 201 having primary and secondarymachines may provide a fault tolerant implementation of the internal GCOPrivate Branch Exchange (PBX). The PBX Cluster 201 may execute theoutbound and inbound calling campaigns (e.g., telephone communicationsbetween or among GCO staff, patients, and other medical serviceproviders) as loaded by the GCO App Server 200. The PBX Cluster 201 mayprovide the auto-dialer services and interactive voice response treesused to define such calling campaigns. The PBX Cluster 201 may alsointerpret any Dual Tone Multi Frequency (DTMF) signals, for example, andtranslate them into meaningful data for transfer to the GCO App Server200. Additionally, PBX Cluster 201 may interpret voice signals intomeaningful commands, which may be passed to GCO App Server 200. In someembodiments, the GCO system may interface with the Public SwitchedTelephone Network (PSTN) in order to establish a voice channel with aremote patient. The diagram of FIG. 9 shows this communication through aVoIP Gateway device. Peripheral systems, e.g., Backup/Reporting Serverand Job Engine 202, may provide supporting activities for the GCO AppServer 200. The Backup/Reporting Server may duplicate the productiondatabase as well as any application files and folders. The Job Enginemay provide for commanding the GCO App Server 200 to execute specificjobs periodically. Additionally, the Job Engine may provide some extracapability regarding data transformation in order to support linking theGCO App Server 200 with external systems.

FIGS. 10A-10B illustrate a use case scenario within a GCO embodiment. Inthe provision of remotely monitoring a patient, the patient may provideperiodic updates to GCO regarding the patient's one or more monitoredmetrics. A monitored metric may be any physical parameter that pertainsto the patient's health, such as blood glucose, blood pressure,temperature, weight, or heart rate, for example. FIGS. 10A-10B show thelogical sequence that follows a determination by the GCO system that amonitor (e.g., an update to a monitored metric) is due. In someembodiments, this scenario may involve five main components, asillustrated by the five columns of FIGS. 10A-10B. GCO Application 150may be the principal source of all business logic associated with GCOservices, specifically remote monitoring as depicted in FIGS. 10A-10B.GCO PBX 101, or Private Branch Exchange, may be a GCO private telephonenetwork that allows for executing inbound and outbound call campaignsassociated with GCO services. FIGS. 10A-10B show two different optionsfor retrieving monitor data from patients: a “DTMF Dongle” or user entryvia voice or keypad. The DTMF Dongle may be part of the package PatientPhone w/DTMF Dongle 102. This DTMF Dongle may be an automated devicethat can automatically send data collected from a monitor device like ablood glucose meter, for example. This data transmission may be doneusing a DTMF signal to encode the monitor data and send it over a voicechannel established with the PSTN. Of course, there are many otheroptions for retrieving data from a monitor device, such as a photographof the device screen, smartphone application using data connection viathe Internet, voice signal, modem transmission, or any other technologythat modulates the analog signal over a voice channel, for example.Though there are many options, the DTMF Dongle embodiment works wellbecause it encodes data in the same manner that a user (e.g., patient orprovider) would enter data through the keypad of a phone. In this way,the GCO PBX 101 can service data entry by the user or data entry by theDTMF Dongle. The remotely monitored patient 103 may receive periodiccontact from GCO regarding the patient's healthcare state. In thisscenario, patient 103 may receive contact from GCO requesting an updateof monitor data. Finally, the GCO Staff 104 may provide general coachingand assistance as needed.

Any wellness plan serviced by GCO, such as diabetes management, forexample, typically may require data entry of patient metrics pertinentto the specific plan. The logical flow shown in FIGS. 10A-10B concerns adetermination that the monitor data for a specific patient is due. Thisdetermination may originate from the GCO Application 150 and may triggera command to the GCO PBX 101 to call the patient 103 and request entryof the monitor data based on a specific outbound call campaign. When theremotely monitored patient 103 answers the phone, he or she may receivea pleasant greeting along with a request to enter the monitorinformation. At this point (see 105), the patient may do so by speakingthe values, taking and transmitting a photograph of the values, keyingthe values on his or her phone, connecting a hard-wired communicationslink between the monitor and the phone, or sending the data with theDTMF Dongle 102. If requested, the specific calling campaign may explainto the remotely monitored patient 103 how to use the monitor device toextract this data and how to use the DTMF Dongle 102 if the patientdesires to do so. The DTMF Dongle 102 may utilize a means to connect tothe monitor device, such as Bluetooth or USB, for example, and extractthe monitor device data. Once extracted, the DTMF Dongle 102 may encodethe monitor device data as a DTMF signal, which is the same mode thepatient may use to send the data if he or she does so with the phone'skeypad. If the remotely monitored patient 103 has any trouble with thecalling campaign instructions, he or she may request assistance, and theGCO PBX 101 may transfer the patient (see 106) to the next available GCOStaff 104. Here the staff member may provide necessary instruction toget the remotely monitored patient entering data with the DTMF Dongle,phone keypad, or voice, for example. Once GCO PBX 101 receives the data,it may transfer the data to the GCO Application 150, which may parse themonitor data entries for specific zones which may broadly fall intovarious classifications (see 107). The classifications may depend on thevalue of the metric but may also depend on values of other metrics asaggregated together. For example, an isolated single systolic bloodpressure of 190 may be treated at a low level of priority, but thepriority may rise if associated with a series of elevated systolic bloodpressures or if associated in the GCO EMR with a patient who had a priorhistory of a hypertensive hemorrhagic stroke. As another example, BodyMass Index (BMI) is a calculated value based on two metrics: height andweight. Taken on their own, height and weight may not fall into anyzones dictating action; however, once the application calculates BMI,its value may fall into various zones dictating response. There may beany number of these zones, such as normal, marginal, warning, orcritical, for example. Given the classification, the GCO Application mayproceed to apply any clinical protocols attached to the classification.The one or more clinical protocols may result in one or more actionsbeing taken. For example, the actions may include creating a task forGCO Staff 104 to execute a follow-up call with the patient, or it mayresult in placing the remotely monitored patient 103 within another callcampaign that may provide specific information to that patient. Asanother example of such action, specific content may be packaged forreview by the remotely monitored patient 103 on the GCO web site via amobile phone, tablet, or PC device, for example. Such content mayinclude, for example, an educational video that explains a specifichealthcare concept pertinent to that specific patient based on thecollected monitor data.

FIG. 11 illustrates a sample embodiment for the DTMF Dongle. The DTMFDongle embodiment can support any number of means to connect to a remotemonitor device, such as a blood glucose meter 300, for example. Thecommunication connection between the DTMF Dongle and the remote monitordevice may occur via any suitable means, such as Bluetooth and/or USB,for example. A DTMF Dongle microprocessor 301 and memory may provide allof the required computational logic to run the various subsystems thatcomprise the DTMF Dongle. In some embodiments, a 3.5 mm headsetinterface 302 may provide the principal means for connecting to thepatient's phone. Using the DTMF Codex/Modem 303 module, the interfacemay allow for transmission of the DTMF encoded signal representing themonitor device data to the GCO App Server 200. Such transmission may bethrough the PSTN and PBX Cluster 201 described above. In someembodiments, the foregoing disclosed components of the DTMF Dongle alongwith the Battery Power System may comprise the core systems required totransmit data over the established voice channel. Given thosecomponents, the DTMF Dongle may be made as small and inconspicuous aspossible. The other components may allow for extension of the DTMFDongle feature set. For example, an RJ-11 Interface w/Pass-thru 304coupled with the modem side of the DTMF Codex/Modem 303 may allow fordirect connection to RJ-11 jacks as typical with established residentialtelephone lines. A User Display/Input 306 may provide additionalguidance to the user when collecting data from a remote monitor deviceand/or transmitting data to the GCO App Server 200. A Speaker and Micmodule 305 may allow the DTMF Dongle to become an integrated callingstation. Given this Speaker and Mic module 305, the patient may use theDTMF Dongle as a speaker phone and communicate with the GCO Staff asrequired and still upload monitor data as well. This integration mayallow for filtering the beeps and bops associated with DTMF and modemtransmission.

Methods for Retrieval of Biometric Data

Various methods of gathering biometric or physiological data areavailable and anticipated for the future to be used in implementing aGCO system as described herein. Each method may be employed with varioussubsets of patient populations based on the requirements of serving eachpopulation. Some or all such methods may comply with the HealthInsurance Portability and Accountability Act (HIPAA) and other industrystandard security requirements, and with FDA, State Medical Board, orany other regulations that may be applicable depending on the specificpopulation and services being rendered.

Self-Reporting: In a self-reporting method, the patient may take ameasurement of a physiological quantity using an FDA certified medicaldevice, for example, and observe the result using the provided humaninterface of that device. The patient may then deliver that measurementdata through one or more mechanisms which may be initiated by either thepatient or the GCO system. For example, the patient may enter such data:

a. Verbally via any voice communication system directly to a carecoordinator, or other designated persons in the navigation center 18,who then may enter the medical data into the GCO electronic system. Theinformation may be conveyed vocally, by TTY, through a translator, or byany other method the patient would normally use for voicecommunications.

b. Via telephone to a standard interactive voice response (IVR) systemcapable of accepting the information via standard DTMF signals enteredby the patient on the keypad, or equivalent, on the patient's voicecommunication device, via speech recognition capable of parsing theinformation from the patient's input, or via any other methods madeavailable by the IVR system.

c. Using a software application on a smart-phone, tablet, personalcomputer, or other device in the patient's possession. The softwareapplication may use any method of data entry available to receive theinput from the patient. The application may deliver that result eitherdirectly to the GCO organization's electronic system, or to a thirdparty entity that then delivers the data to the GCO system.

d. Through a website, or equivalent remote software portal, where thepatient can authenticate his or her identity and report result data fromany capable device such as a computer, smart device, or public terminal,for example.

e. Through a standard fax system by rendering the data in written formand faxing that rendering. The rendered fax image may then be parsed bya standard optical character recognition system and entered into theelectronic GCO system, and/or by a human that interprets the renderedimage and enters the data into the electronic GCO system.

f. Through any combination of the foregoing methods or any other methodsin which the patient gathers the information from a medical device andreports that data to the GCO organization.

MDDS: In an MDDS method, the patient may take a measurement using an FDAcertified medical device, for example, and the result may be observed byanother device and/or system classified as an exempt Medical Device DataSystem (MDDS), or other equivalent FDA exemption, for example. The MDDSmay deliver the data through one or more mechanisms to the GCOorganization directly or to a third party entity that then delivers thedata to the GCO organization. An MDDS method may involve:

a. Reading results from the medical device by:

i. Connecting to the medical device electronically, such as via USB,Bluetooth, Wi-Fi, Serial, or similarly capable connections that allowthe MDDS system to observe the medical device's result; or

ii. Reading the results from the medical device using the provided humaninterface of that device in a way approximating the method used by ahuman. For example, such methods may include using a camera to visuallygather information from the device and interpreting the image for thedata (e.g., Vital Snap™ available from Validic (Durham, N.C.)),listening to a device with audio feedback components and parsing thesounds for the data, or any other sense interfaces.

b. Reporting the data back to the GCO organization directly, or througha third party intermediary:

i. As secured electronic data transported via the Internet, privatenetwork, cell network, or any other equivalent digital data transport;or

ii. Using standard voice communication paths and rendering the data ashuman speech utilizing a text-to-speech software engine. The resultingsynthetic human speech transmission may be received, decoded,redundantly tested for accuracy, and entered into the GCO organization'selectronic system by an interactive voice response (IVR) system, and/orby a human representative of the GCO organization; or

iii. Using standard voice communication paths and rendering the data asencoded sounds. The data may be encoded as standard DTMF tones, othertonal frequency encoding, rhythmic encoding like Morse code, forexample, or any other method of encoding data into audible signals. Theresulting encoded data may be received, decoded, and entered into theGCO organization's electronic system by a software system capable ofdecoding the audio.

FDA Certified Medical Device: For some patient populations, an FDAcertified medical device that includes delivery of the results data viaFDA certified methods may be required.

a. FDA certified medical devices and their data delivery systems maytake many forms with many different delivery methods. Some of thosecertified delivery methods are the same, or similar to, MDDS deliverysystems mentioned previously but meet more stringent regulatorystandards.

b. FDA certified systems usually deliver data to a third party certifiedelectronic system. The GCO organization's human agents may then accessthe data directly through the third party's software interface, and/orautomated connections may be made between the third party system and theGCO organization's electronic system.

Passive Systems

a. It is anticipated that systems available in the future may collectand deliver data differently from currently available technology.

i. Future devices and delivery systems may gather continuous data anddeliver a pre-processed subset of information as needed, or they mayjust deliver data at scheduled intervals without requiring discreetconscious action by the remote patient.

ii. Future control-independent devices may use the same or similarmethods of reporting data as previously described.

iii. Future devices, or current devices with modification, may utilizesome new method of transporting the result data to a central system.

b. The GCO organization's electronic systems may be constructed so thatthese changes in technical details of transporting information from thepatient's medical sensors to the GCO organization's electronic system donot fundamentally change the GCO organization's electronic systems.

As persons of ordinary skill in the art will appreciate, in someembodiments, systems and methods described herein may involve replacingsome rote activities within the healthcare arena currently executed bystaff with automated processes. For example, such activities mayinclude: (a) providing feedback to the patient based on medical history,which may include but is not limited to blood pressure trends, bloodglucose trends, medication list, family history, and appointmenthistory, using feedback routes to the patient via any number of suitablemodalities including but not limited to text, email, web application,outbound call campaigns, or any combination thereof, wherein thefeedback content may include but is not limited to voice, video, text,slideshows, pictures, or any combination thereof which providesinformation to the patient specific to his or her current state; and (b)reminding the patient concerning obligations based on their diseasestate, which reminders may include but are not limited to upcomingappointments, required lab test due, and entry of remote monitor data,for example. In some embodiments, such systems and methods may handlesuch automated tasks only as directed by approved clinical protocols. Insome embodiments, those same protocols may direct inclusion of a medicalprofessional to follow-up with the patient.

In some embodiments, such systems and methods may involve implementingan automated method for gathering remote monitor values from thepatient. Examples of remote data acquisition may include, but are notlimited to, data entry via voice channels, transmission of a picture ofa monitor display, data upload via any network/Internet protocol (HTTP,HTTPS, FTP, FTPS, SFTP, and the like). The transport modes over a voicechannel may include, but are not limited to, analog singlemodulation/demodulation (e.g., the ubiquitous modem or any other schemeencoding data such as Dual Tone Multi Frequency, or DTMF) and voiceitself. The remote data acquisition may occur via a remotely establishedgateway device that serves as an interface to the transport medium. Suchgateway device may include, but is not limited to, a commercial product(e.g., cable modem, cell router, and the like), a specifically designedgateway device (such as a DTMF dongle), or the patient's existinggateway infrastructure (e.g., cell phone, tablet, PC, or the likecommunicating directly to the network medium or running through anestablished gateway device within the home).

In some embodiments, systems and methods described herein may includeproviding the patient with medical history, medical record update, anddisease state education on demand Such provision may be embodied byaccess to a web host that provides content to the patient as requestedgiven proper authentication. Such request and response interaction maybe initiated by the patient through a mobile application or webapplication, for example. Such interaction may also occur via aspecifically designed device used by the patient.

Persons of ordinary skill in the art will understand that the systemsand methods described herein may be implemented via one or morecomputers, which may have one or more memories programmed with one ormore programs on one or more computer readable media. Although only onecentral computer 112 is shown, two or more such computers may beemployed, depending on the needs of the particular application. Amongother things, the various components and functionalities illustrated inthe Figures and described herein may be implemented on the same computeror different computers and in one or more pieces of software. Anyfeature described for one embodiment may be used in any otherembodiment. Persons of ordinary skill in the art will also understandthat various changes may be made to the systems and methods describedherein without departing from the scope of the invention. Therefore, theinvention is to be construed in accordance with the claims attachedhereto and is not to be limited to the embodiments described herein.

Definitions

As used herein, the following terms should be understood to have theindicated meanings, unless the context reveals otherwise.

“Communication” means the transmission of one or more signals from onepoint to another point. Communication between two objects may be direct,or it may be indirect through one or more intermediate objects.Communication in and among computers, I/O devices and network devicesmay be accomplished using a variety of protocols. Protocols may include,for example, signaling, error detection and correction, data formattingand address mapping. For example, protocols may be provided according tothe seven-layer Open Systems Interconnection model (OSI model), theTCP/IP model, or any other suitable model.

“Comprises” means includes but is not limited to.

“Comprising” means including but not limited to.

“Computer” means any programmable machine capable of executingmachine-readable instructions. A computer may include but is not limitedto a general purpose computer, mainframe computer, microprocessor,computer server, digital signal processor, personal computer (PC),personal digital assistant (PDA), laptop computer, desktop computer,notebook computer, smartphone (such as Apple's iPhone™, Motorola'sAtrix™ 4G, and Research In Motion's Blackberry™ devices, for example),tablet computer, netbook computer, portable computer, portable mediaplayer with network communication capabilities (such as Microsoft's ZuneHD™ and Apple's iPod Touch™ devices, for example), camera with networkcommunication capability, wearable computer, point of sale device, or acombination thereof. A computer may comprise one or more processors,which may comprise part of a single machine or multiple machines.

“Computer readable medium” means a non-transitory article of manufacturehaving a capacity for storing one or more computer programs, one or morepieces of data, or a combination thereof. A computer readable medium mayinclude but is not limited to a computer memory, hard disk, memorystick, magnetic tape, floppy disk, optical disk (such as a CD or DVD),zip drive, or combination thereof.

“GUI” means graphical user interface.

“Having” means including but not limited to.

“Interface” means a portion of a computer processing system that servesas a point of interaction between or among two or more other components.An interface may be embodied in hardware, software, firmware, or acombination thereof.

“I/O device” may comprise any hardware that can be used to provideinformation to and/or receive information from a computer. Exemplary I/Odevices may include disk drives, keyboards, video display screens(including GUIs), mouse pointers, joysticks, trackballs, printers, cardreaders, scanners (such as barcode, fingerprint, iris, QR code, andother types of scanners), RFID devices, tape drives, touch screens,cameras, movement sensors, network cards, storage devices, microphones,audio speakers, styli and transducers, and associated interfaces anddrivers.

“Memory” may comprise any computer readable medium in which informationcan be temporarily or permanently stored and retrieved. Examples ofmemory include various types of RAM and ROM, such as SRAM, DRAM, Z-RAM,flash, optical disks, magnetic tape, punch cards, EEPROM, andcombinations thereof. Memory may be virtualized, and may be provided inor across one or more devices and/or geographic locations, such as RAIDtechnology, for example.

“Network” may comprise a cellular network, the Internet, intranet, localarea network (LAN), wide area network (WAN), Metropolitan Area Network(MAN), other types of area networks, cable television network, satellitenetwork, telephone network, public networks, private networks, wired orwireless networks, virtual, switched, routed, fully connected, and anycombination and subnetwork thereof. A network may use a variety ofnetwork devices, such as routers, bridges, switches, hubs, repeaters,converters, receivers, proxies, firewalls, translators and the like.Network connections may be wired or wireless, and may use multiplexers,network interface cards, modems, ISDN terminal adapters, line drivers,and the like. A network may comprise any suitable topology, such aspoint-to-point, bus, star, tree, mesh, ring, and any combination orhybrid thereof.

“Program” may comprise any sequence of instructions, such as analgorithm, for example, whether in a form that can be executed by acomputer (object code), in a form that can be read by humans (sourcecode), or otherwise. A program may comprise or call one or more datastructures and variables. A program may be embodied in hardware,software, firmware, or a combination thereof. A program may be createdusing any suitable programming language, such as C, C++, Java, Perl,PHP, Ruby, SQL, other languages, and combinations thereof. Computersoftware may comprise one or more programs and related data. Examples ofcomputer software may include system software (such as operating systemsoftware, device drivers and utilities), middleware (such as webservers, data access software and enterprise messaging software),application software (such as databases, video games and media players),firmware (such as software installed on calculators, keyboards andmobile phones), and programming tools (such as debuggers, compilers andtext editors).

“Signal” means a detectable physical phenomenon that is capable ofconveying information. A signal may include but is not limited to anelectrical signal, an electromagnetic signal, an optical signal, anacoustic signal, or a combination thereof.

The invention claimed is:
 1. A computer-assisted patient navigation andcommunication system that receives communications from a patientregarding the patient's symptoms, scans patient data to determine themedical needs of the patient, and displays information to navigationpersonnel who can quickly navigate the patient to the most appropriatemedical provider and/or information responding to the patient'ssymptoms, said system comprising: a) a call center having saidnavigation personnel who navigate the patient to the most appropriateresponse by either (i) providing assessment, diagnosis, treatment,and/or education to said patient, or (ii) further navigating the patientto the most appropriate medical provider inside or outside the callcenter for assessing, diagnosing and/or treating the patient's symptoms;and b) said call center having facilities for communications betweensaid patient and said navigation personnel, said facilities beingarranged and configured for receiving, recording and displaying patientcommunications and/or patient physiological data from one or more of thefollowing sources: patient's oral or electronic communications,patient's video communications, physiological monitors possessed by thepatient, patient physiological monitors located at remote facilities,patient physiological data in the patient's electronic health records,and/or data obtained from health care personnel associated with thepatient; c) wherein said communications and patient physiological dataenable said navigation personnel to assess, diagnose, treat, educate,and/or refer said patient to education materials regarding a specifichealth problem, a self-care video, a laboratory, imaging facility,pharmacy, home health personnel, physical therapist, ambulance facility,hospital, emergency room, physician and/or medical specialist respondingto the patient's identified symptoms.
 2. The system according to claim1, wherein personnel qualifications of said navigation personnel andsaid medical providers are input in the system and associated withpatient symptoms, patient chronic diseases and/or patient communicationbarriers.
 3. The system according to claim 2, wherein personnelqualifications of each navigation personnel and medical provider includeone or more of the following: credentials, areas of special knowledge,and languages spoken.
 4. The system according to claim 3, furthercomprising algorithms for first verifying the correctness of theincoming patient physiological data, and then weighting the patientcommunications and patient physiological data, and associating certainnavigation personnel and medical providers with specific conditions andsymptoms.
 5. The system according to claim 1, wherein said navigationpersonnel consist of health care providers defined as physicians,physician assistants or nurses.
 6. The system according to claim 1,wherein said call center is a virtual call center.